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Poster Display

1169 - Clinical significance of serum factors relating to ERBB signal pathways in a phase II trial of S-1 plus cisplatin combined with trastuzumab for HER2-positive advanced gastric or esophagogastric junction cancer: WJOG7212G (T-SPACE) TR study


08 Oct 2016


Poster Display


Yasutaka Sukawa


Annals of Oncology (2016) 27 (6): 207-242. 10.1093/annonc/mdw371


Y. Sukawa1, K. Nosho2, Y. Miura3, T. Takano3, M. Ito2, K. Yonesaka4, M. Mori5, S. Tokunaga6, J. Kawada7, H. Okuda8, T. Sakamoto9, Y. Hirashima10, K. Uchino11, Y. Miyata12, K. Yoshimura13, K. Yamazaki14, S. Hironaka15, N. Boku16, I. Hyodo17, K. Muro18

Author affiliations

  • 1 Division Of Gastroenterology And Hepatology, Keio University School of Medicine, 1608582 - Tokyo/JP
  • 2 Department Of Gastroenterology, Rheumatology And Clinical Immunology, Sapporo Medical University, Sapporo/JP
  • 3 Depertment Of Medical Oncology, Toranomon Hospital, 105-8470 - Tokyo/JP
  • 4 Department Of Medical Oncology, Kindai UniversityFaculty of Medicine, Osaka/JP
  • 5 Department Of Clinical Oncology, Jichi Medical University, Tochigi/JP
  • 6 Medical Oncology, Osaka City General Hospital, Osaka/JP
  • 7 Department Of Surgery, Osaka General Medical Center, Osaka/JP
  • 8 Department Of Medical Oncology, Keiyukai Sapporo Hospital, 003-0027 - Sapporo/JP
  • 9 Department Of Gastroenterological Oncology, Hyogo Cancer Center, Akashi/JP
  • 10 Department Of Medical Oncology And Hematology, Oita University Faculty of Medicine, Oita/JP
  • 11 Department Of Medical Oncology, National Hospital Organization Kyusyu Medical Center, Fukuoka/JP
  • 12 Department Of Medical Oncology, Saku Central Hospital Advanced Care Center, Nagano/JP
  • 13 Innovative Clinical Research Center, Kanazawa University Hospital, Kanazawa/JP
  • 14 Division Of Gastrointestinal Oncology, Shizuoka Cancer Center, 411-8777 - Shizuoka/JP
  • 15 Clinical Trial Promotion Department, Chiba Cancer Center, 260-8717 - Chiba/JP
  • 16 Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo/JP
  • 17 Division Of Gastroenterology, University of Tsukuba, 305-8577 - Tsukuba/JP
  • 18 Department Of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya/JP


Abstract 1169


No biomarker other than HER2 expression for anti-HER2 therapy has been established in gastric cancer. We explored serum ERBB-related biomarkers for efficacy in a phase II trial (WJOG7212G) of triweekly trastuzumab (Tmab) (first dose 8 mg/kg then 6mg/kg) in combination with 5-weekly S-1 (40-60mg, twice daily, for 21 days) plus cisplatin (60mg/m2, on day 8) for HER2-positive (IHC3 + , or IHC2+ and FISH+) advanced gastric or esophagogastric junction cancer.


Serum samples were collected in 31 of 44 patients enrolled in the phase II study. Serum HER2, EGF, TGF-alpha, neuregulin 1 (NRG1), HGF, IGF1 and TIMP1 were measured by ELISA at following 4 points; pre-treatment, immediately before 2nd and 4th Tmab administration, and after PD. Pre-treatment serum levels were compared between responders (CR + PR) and non-responders (SD + PD). Progression free survival (PFS) and overall survival (OS) were compared between the high and low groups divided at median of pre-treatment value of each serum marker.


Patient characteristics were: median age 65.0 years, males 23 (74%), PS 0-1 29 (93%), primary site of stomach 27 (87%), histology of diffuse type 14 (45%), IHC 3+ 22 (71%) patients. The response rate was 68% (95% CI 50 - 81). The median PFS was 183 days (95% CI 133 - 420). The median OS was 515 days (95% CI 373 - not reached). Pre-treatment HER2 and NRG1 levels were higher in responders than in non-responders (Mean; HER2 96 ± 68 ng/ml vs. 12 ± 2 ng/ml, p = 0.026, NRG1 2467 ± 886 pg/ml vs. 186 ± 186 pg/ml, p = 0.012). HER2, NRG1 and EGF levels decreased after treatment (p 


Serum NRG1 may be a candidate of a predictive marker for the efficacy of Tmab in combination with S-1 plus cisplatin in patients with HER2 positive gastric or esophagogastric junction cancer.

Clinical trial identification

Protocol number: UMIN000008389; Release date: 9, July, 2012

Legal entity responsible for the study

West Japan Oncology Group


Taiho Pharmaceutical Co.,Ltd.


Y. Miura: Honoraria: Kyowa Hakko Kirin, Novartis. T. Takano: Honoraria: Chugai, Taiho. K. Yamazaki: Honoraria: Chugai, Taiho. S. Hironaka: Honoraria: Taiho. N. Boku: Honoraria: Taiho, Chugai, Bristol-Myers. I. Hyodo: Honoraria: Daiichi-Sankyo, Chugai, Taiho, Yakult Pharmaceutical Companies. All other authors have declared no conflicts of interest.

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